Tris Pharma Inc. recalls Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension, (equivalent to 10 mg hydrocodone
Tris Pharma recalls Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension due to high drug levels that could cause serious harm. This Rx-only product was manufactured with NDC 27808-086-02, lot 14079, expiring 10/2021.
Stop using this now
Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.
Contact the company & request your remedy
What happened, in plain English
Tris Pharma is recalling Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension because the drug levels are too high, which could cause serious harm. This is a prescription-only product that was manufactured with specific lot and expiration details. Read more at govinfonow.com/recall/38334-tris-pharma-hydrocodone-polistirex-recall-high-drug-levels-risk-serious.
Source Summary by GovInfoNow · govinfonow.com/recall/38334-tris-pharma-hydrocodone-polistirex-recall-high-drug-levels-risk-serious · Updated October 5, 2026 · FDA enforcement record: FDA #D-1517-2019
Cite this page
“Tris Pharma Hydrocodone Polistirex Recall: High Drug Levels Risk Serious Harm.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38334-tris-pharma-hydrocodone-polistirex-recall-high-drug-levels-risk-serious. Based on FDA recall #D-1517-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1517-2019%22&limit=1).
Why it’s dangerous
The product contains high levels of hydrocodone and chlorpheniramine, which can cause serious harm like overdose or severe side effects. The preservatives also failed stability specifications, meaning the medication may degrade quickly and become unsafe.
Who’s affected
Prescription holders of the Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension (16 fl. oz. bottles) with NDC 27808-086-02 and lot 14079 are affected. People taking this medication for pain or allergies are at risk of serious harm due to the high drug levels.
How to tell if you have this one
Check for the 16 fl. oz. (473 mL) bottle labeled 'Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension' with NDC 27808-086-02 and lot number 14079. This prescription-only product expires October 2021.
- Brand
Tris Pharma- Category
Drug
What to do — step by step
Stop using it now
Immediately stop using the recalled Hydrocodone Polistirex and Chlorpheniramine Polistirex Extended-Release Suspension if you have the specific lot and NDC number.
Questions people ask
Is this product safe to use?
No, the product has high drug levels that could cause serious harm, so it should not be used.
What should I do if I have this product?
Stop using it now and contact your doctor for alternative medication options.
How can I check if I have the recalled product?
Look for the 16 fl. oz. bottle with NDC 27808-086-02 and lot number 14079, which expires October 2021.
Contact Tris Pharma
We’ve drafted a message you can send Tris Pharma to request your refund or repair — edit it as you like.
Subject: Recall D-1517-2019 — Tris Pharma Tris Pharma Hello, I own a Tris Pharma that is covered by recall D-1517-2019 from Tris Pharma. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1517-2019 (July 11, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1517-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.